Acuvance2 Safety Catheter, Product No. 1720-AI recallZ-0789-2017 · Smiths Medical ASD Inc. · initiated Nov 21, 2016
Class II Terminated All recalls posted in December 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
FDA root cause category: Process control
What the company is doing
Consignees were sent on 11/21/2016 a Smiths Medical "Urgent Medical Device Field Safety Notice: dated November 18, 2016. The letter was addressed to "Clinician who uses the Acuvance2 Safety Catheter". The letter described the Reason for Recall, Risk to Health, and Instructions to Customers. Requested consignees to complete and return the "Urgent Medical Device Field Safety Notice Response Form" within 10 days of receipt. For questions contact Stericycle via email at the [email protected].
Recall details
- Recall number
- Z-0789-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 21, 2016
- Posted by the FDA
- Dec 19, 2016
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 26,750
- Product code
- FOZ
- FDA submissions
- K012128
- Distribution
- Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Product description
Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN) designed to reduce risk of accidental needle sticks to the operators. The lateral port is equipped with a non-return silicone valve and a polypropylene snap cap with a winged polypropylene hub for fastening.
Code information (models, lots, serial numbers)
3120882, 3120883, 3220733
Other devices under the same FDA submission
5 devices cleared under K012128 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Jelco 335603Icu Medical, Inc. · Catheter,intravascular,therapeutic,short-term less than 30 days13 reports
- Jelco 338300Icu Medical, Inc. · Catheter,intravascular,therapeutic,short-term less than 30 days8 reports
- Jelco 335703Icu Medical, Inc. · Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Jelco 335503Icu Medical, Inc. · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- Jelco 335903Icu Medical, Inc. · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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